Teva Pharmaceutical Industries Ltd. (Nasdaq: TEVA; TASE: TEVA) announced at the end of last week that the US Food and Drug Administration (FDA) has granted tentative approval for the company's abbreviated new drug application (ANDA) to market its generic version of Wyeth's Protonix (pantoprazole sodium) delayed release (DR) tablets, 20 mg and 40 mg.
Upon final approval, Teva's pantoprazole sodium DR tablets will be the AB-rated equivalent of Protonix DR tablets, a product indicated for short term treatment of erosive esophagitis associated with gastroesophageal reflux disease (GERD), maintenance of healing of erosive esophagitis and for treatment of hypersecretory conditions.
Teva noted that annual brand product sales in the US were approximately $2.4 billion for the twelve months ended December 2005.
Teva further noted that it is currently in patent litigation concerning this product in the US District Court for the District of New Jersey. A suit was brought against Teva in May 2004. A trial date has not been set.
Teva stated that final approval is expected either after a favorable decision in the case, or the expiry of the mandatory stay of approval in August 2007, whichever is earliest.
Published by Globes [online], Israel business news - www.globes.co.il - on April 23, 2006
© Copyright of Globes Publisher Itonut (1983) Ltd. 2006